Remember the desperate look of those patients in the movie "The God of Medicine"? They can't afford the original drug.
In recent years, in the global pharmaceutical market, biosimilar drugs are rapidly increasing in the field of immune diseases and cancer treatment due to their strong price advantage, better efficacy and lower side effects. Can biosimilar drugs replace the original drug? Biosimilars, also known as biosimilars, are biosimilars (including vaccines, blood and blood components, somatic cells, gene therapy, tissue and recombinant therapeutic proteins, etc.) similar to approved biosimilars.
Recently, Guohai Securities released an in-depth report on the biosimilar drug industry. The report points to four highlights of the industry:
1. Biosimilar drugs are the new engine for the growth of the global biopharmaceutical market;
2, biosimilar drugs can quickly seize market share by virtue of price advantage, biosimilar drug companies with first-mover advantage can often take the lead;
3. It is expected that the penetration rate of biosimilar drugs in Chinese patients will further increase in the future;
4. In the next 1-2 years, it is expected that more than 5 biosimilar drugs will be approved for listing, and the competition pattern dominated by foreign companies will gradually be broken.
The scale of the global biosimilar drug market is in a period of rapid growth, and its growth rate far exceeds that of the original biopharmaceutical. According to IMS statistics, the global biopharmaceutical market size in 2016 was US$228 billion, and the 2012-2016 CAGR was 8.9%. The global biosimilar drug market is still in its infancy, with a small scale but a high growth rate. In 2016, the global market for biosimilar drugs was US$1.4 billion, and the 2012-2016 CAGR was 28.7%. As more and more monoclonal antibodies are approved, the market growth rate of biosimilar drugs is on the rise.
So, what kind of trend does China's biosimilar drug industry show? Is it an inevitable trend to replace the original drug with a biosimilar drug?
Good policy
The report pointed out that China's biosimilar drug approval policy is gradually in line with international standards, which is expected to reduce the company's research and development costs. In December 2014, the State Food and Drug Administration issued the “Guidelines for the Development and Technical Guidance of Biosimilar Drugs (Draft for Comment)â€; in March 2015, the “Guidelines for the Development and Technology of Biosimilar Drugs (Trial)†was promulgated ( Hereinafter referred to as the “Guidelines for Guidanceâ€; in 2016, the “Regulations on the Administration of Drug Registration (Revised Draft)†further standardized the concept and approval criteria for biosimilar drugs. These policies issued by the regulatory authorities have great guiding significance for the development of biosimilar drugs, and the EU and FDA have corresponding guidelines.
Europe is the earliest region for the development of the biosimilar drug market, and it is also the first region in the world to introduce biosimilar drug-related policies. The first edition of the biosimilar drug guidelines was enacted in 2005 and the first biosimilar drug was approved in 2006.
The US biosimilar drug market started late. In 2010, the US government developed a simplified application route for biosimilar drugs to enter the market, and the first biosimilar drug was officially approved in 2015.
At present, in China, rituximab-like drugs, bevacizumab-like drugs, and adalimumab-like drugs have been submitted for approval, and many companies have entered phase III clinical trials. It is expected to see more than 5 in the next 1-2 years. Biosimilar drugs were approved for marketing.
Medical insurance improves purchasing power
China's monoclonal antibody drugs have been completely self-funded from the beginning, and have experienced the process of partial medical insurance coverage, national medical insurance coverage, and national medical insurance negotiations. With the increase in coverage of medical insurance, the purchasing power of patients will also be greatly enhanced, and it will also provide strong support for the development of biosimilar drugs in China, speeding up market introduction and volume.
Before 2009, the monoclonal antibody drugs were all at their own expense. After 2009, 7 monoclonal antibody products entered the category B medical insurance catalog.
In February 2017, the Ministry of Human Resources and Social Security announced the new medical insurance catalogue, and the first two monoclonal antibody drugs were included in the national Class B medical insurance.
On April 14, 2017, in the scope of negotiations on the medical insurance drug list issued by the Ministry of Human Resources and Social Security, 8 monoclonal antibody products were included in the negotiating drug list. On July 19, the results of the negotiations were announced, and 6 monoclonal antibody negotiations were successfully included in the medical insurance. table of Contents.
Domestic biosimilar drugs will rise?
According to the data, the monoclonal antibody is the largest and fastest growing market share of the domestic biopharmaceutical market except for blood products. In the share of localization, the share of domestically produced companies with monoclonal antibodies is only 15%, and there is room for growth in the future. The report pointed out that monoclonal antibody-like drugs will become the biggest development opportunity in China's biopharmaceutical market.
Now, many hot targets have entered the late stage of research and development, and domestic biosimilar drugs seem to rise.
In the case of rituximab, rituximab is by far the most commercially successful CD20 monoclonal antibody. In 2017, Roche's rituximab achieved sales of 7.388 billion Swiss francs worldwide. Converted into RMB 48.6 billion. As early as 2000, Roche's rituximab was approved for listing in China. Among the domestic CD20 monoclonal antibodies, Fuhong Hanlin has the fastest progress in research and development and is already in the application for listing. Therefore, the current domestic CD20 monoclonal antibody market is still dominated by Roche's rituximab, and Fuhong Hanlin's rituximab-like drug is hopeful to break this situation.
The report predicts that for the three indications of diffuse large B-cell lymphoma, follicular B-cell lymphoma and rheumatoid arthritis, the future market space of CD20 monoclonal antibody in China can reach about 4 billion yuan. Fuhong Hanlin's rituximab-like drug, as the first drug to break the original monopoly of Rituxan in the domestic market, is expected to occupy 50% of the market share in the future, so its peak sales are expected to reach 2 billion yuan.
It can be seen that the development prospect of biosimilar drugs can be described as bright, can it replace the original drug? Professor Li Zhiming, director of the Department of Internal Medicine of the Cancer Center of Sun Yat-sen University, said in an interview that for biosimilar manufacturers, they must develop new cell lines, independently re-engineer the entire manufacturing process, and achieve similar efficacy and safety of the original drug. Sex, to be verified. Regarding the safety and effectiveness of biosimilar drugs, the state has also introduced relevant policy supervision. If the efficacy and safety of biosimilar drugs can be consistent with the original drug in the future, this can also give doctors and patients an alternative.
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